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Boulder, CO /PRNewswire/ - ArcherDX, Inc. and Premier Inc., a leading healthcare improvement company, announced today that they have signed a two-part agreement, kicking off a multi-year program. Premier Applied Sciences® will identify eight to 10 member institutions that will implement STRATAFIDE – in a research use only (RUO) capacity – to participate in a retrospective study to evaluate its sequencing performance in comparison to other diagnostic tests. ArcherDX plans to seek approval from the U.S. Food and Drug Administration (FDA) for STRATAFIDE as a genomic sequencing in vitro diagnostic (IVD) cancer assay capable of analyzing both tissue and blood samples. The ultimate goal of the partnership is to help solve for the underutilization of targeted therapies in late-stage cancer patients.
"Genomic testing has resulted in clear benefit at multiple stages in the fight against cancer. However, there remains a stark need for a kitted IVD solution designed for broader use in any hospital's molecular diagnostic laboratory," said Jason Myers, Chief Executive Officer and co-founder, ArcherDX. "Premier shares our commitment to providing actionable, accurate information to patients and healthcare providers in a community setting, where clinicians are empowered to control the sample, data and economics. This agreement provides for both a clinical and commercial collaboration, and we are pleased to partner with such a forward-thinking healthcare enterprise dedicated to serving more than 4,000 U.S. hospitals and health systems and approximately 175,000 other providers."
ArcherDX and Premier's research team will identify retrospective samples from patients with lung, thyroid and colorectal cancer to be analyzed by Archer Clinical Services. The study aims first to evaluate STRATAFIDE as a composite test to identify genomic alterations associated with cancer. The expanded collaboration intends to further understand best practices to implement and utilize a distributed IVD in community hospital settings, which may currently lack advanced molecular genomics tools.
"Our partnership with ArcherDX demonstrates the expanse of Premier's research portfolio so that it is now engaged in next-generation sequencing for multiple forms of cancer in various provider settings," said Stella A. Safo, M.D., MPH, Chief Clinical Transformation Officer and Vice President for Premier Applied Sciences. "We hope this research will help accelerate appropriate cancer care for hard to reach populations and are thrilled to be working with an innovative team that has the potential to bring accurate and actionable genomic data to patients and their caregivers everywhere. This represents a critical unmet need since so many cancer patients lack access to genomic testing and therapy selection tools in their communities."
The financial terms of the collaboration were not disclosed.
ArcherDX is a leading genomic analysis company democratizing precision oncology through a suite of products and services that are highly accurate, personal, actionable and easy to use in local settings. Our Archer® platform, with our proprietary Anchored Multiplex PCR (AMP™) chemistry at the core, has enabled us to develop industry-leading products and services to optimize therapy and enable cancer monitoring across sample types. We develop and commercialize research use only (RUO) products, are developing in vitro diagnostic (IVD) products, and offer services that meet the unique needs of our customers and their clinical applications. Our RUO product portfolio consists of VariantPlex®, FusionPlex®, LiquidPlex™ and Immunoverse™, which we collectively refer to as ArcherPlex™. IVD products currently in development for solid tumor biomarker identification and Personalized Cancer Monitoring (PCM) have both received Breakthrough Device Designation from the FDA. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
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i Singal, G, et al. JAMA 2019; 321(14): 1391-1399.